Australia's Federal Court held in Cancer Voices Australia v Myriad Genetics Inc, [2013] FCA 65, that a valid patent may be granted, under the category of 'a manner of manufacture', for naturally occurring nucleic acid (either DNA or RNA) that has been 'isolated' -- which is to say, 'removed from the cellular environment in which it naturally exists and separated from other cellular components also found there'.

Myriad Genetics and an Australian licensee have been seeking patent protection for mutations of the human gene that indicates a hereditary risk of breast or ovarian cancer. The applicants in the Australian litigation were concerned that ownership of IP rights in the gene may inhibit research and testing by third parties. The court reasoned that the gene was a product consisting of 'an artificial state of affairs' with 'a new and useful economic effect' (which would be the valid subject of a patent) rather than something that was 'not materially different to nucleic acid found in nature' (which, as a 'product of nature' or 'mere discovery', would not). It was not a claim to the patentability of DNA or RNA as they occur naturally in the cells of the human body, or to the underlying genetic information. The process of isolating nucleic acid necessarily resulted in the 'artificial state of affairs' upon which a patent for 'a manner of manufacture' must be predicated, given the high degree of human intervention that is required to achieve this.

Compare and contrast Association for Molecular Pathology v Myriad Genetics Inc (US Supreme Court, 13 June 2013), where the court held that a naturally occurring DNA segment is a product of nature and not eligible for patent protection merely because it has been isolated. Patent protection is, on the other hand, available for cDNA (synthetically created, complementary DNA) because it is created in the lab and not in nature.

http://www.austlii.edu.au/au/cases/cth/FCA/2013/65.html

http://s3.documentcloud.org/documents/713216/scotusgenedecision.pdf